A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer
- Conditions
- Urinary Bladder NeoplasmsMuscle-Invasive Bladder Cancer
- Interventions
- Registration Number
- NCT03661320
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to compare nivolumab plus neoadjuvant gemcitabine/cisplatin (GC) chemotherapy, followed by post-surgery continuation of immuno-oncology (IO) therapy, with neoadjuvant GC chemotherapy alone in adult participants with previously untreated muscle-invasive bladder cancer (MIBC).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 861
- Participant must be deemed eligible for Radial Cystectomy (RC) by his/her oncologist and/or urologist, and must agree to undergo Radial Cystectomy (RC) after completion of neoadjuvant therapy.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Clinical evidence of positive lymph node(s) (LN) (≥ 10 mm in short axis) or metastatic bladder cancer
- Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than trans urethral resection of bladder tumor (TURBT) or biopsies is also not permitted
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B: Nivolumab + GC Chemotherapy Nivolumab - Arm B: Nivolumab + GC Chemotherapy Cisplatin - Arm A: Gemcitabine/Cisplatin (GC) Chemotherapy Cisplatin - Arm A: Gemcitabine/Cisplatin (GC) Chemotherapy Gemcitabine - Arm B: Nivolumab + GC Chemotherapy Gemcitabine -
- Primary Outcome Measures
Name Time Method Pathological Complete Response (pCR) rate, in all randomized participants Approximately 43 months Arm B vs. Arm A
Event-Free Survival (EFS), in all randomized participants Approximately 51 months Arm B vs. Arm A
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) in all randomized participants Approximately 60 months Arm B vs. Arm A
Incidence of Adverse Events (AE) in participants who received at least one treatment dose Approximately 60 months Incidence of Serious Adverse Events (SAE) in participants who received at least one treatment dose Approximately 60 months Incidence of deaths in participants who received at least one treatment dose Approximately 60 months Incidence of laboratory abnormalities in participants who received at least one treatment dose Approximately 60 months pCR rate, descriptively in all concurrently randomized participants Approximately 43 months Arm C vs. Arm B and Arm A
EFS, descriptively in all concurrently randomized participants Approximately 51 months Arm C vs. Arm B and Arm A
OS, descriptively in all concurrently randomized participants Approximately 60 months Arm C vs. Arm B and Arm A
Trial Locations
- Locations (171)
Local Institution - 0146
🇫🇮Turku, Finland
Local Institution - 0013
🇩🇪Herne, Germany
Local Institution - 0060
🇧🇪Bruxelles, Belgium
Local Institution - 0062
🇧🇪Wilrijk, Belgium
Local Institution - 0214
🇧🇷Sao Paulo, Brazil
Local Institution - 0151
🇦🇷Ciudad Autonoma Buenos Aires, Distrito Federal, Argentina
Local Institution - 0143
🇦🇺North Adelaide, South Australia, Australia
Local Institution - 0099
🇧🇷Ipatinga, Minas Gerais, Brazil
Local Institution - 0157
🇦🇺Macquarie University, New South Wales, Australia
Local Institution - 0182
🇨🇦North York, Ontario, Canada
Local Institution - 0006
🇺🇸Peoria, Illinois, United States
Local Institution - 0069
🇺🇸Lake Success, New York, United States
Local Institution - 0043
🇦🇺St Leonards, New South Wales, Australia
Local Institution - 0037
🇦🇺Heidelberg, Victoria, Australia
Local Institution - 0130
🇦🇺Kingswood, New South Wales, Australia
Local Institution - 0084
🇩🇪Luebeck, Germany
Local Institution - 0063
🇧🇪Gent, Belgium
Local Institution - 0078
🇩🇪Aachen, Germany
Local Institution - 0131
🇦🇺Garran, Australian Capital Territory, Australia
Local Institution - 0164
🇧🇷Rio De Janeiro, Brazil
Local Institution - 0205
🇫🇷Amiens, France
Local Institution - 0016
🇩🇪Nuernberg, Germany
Local Institution - 0093
🇧🇷Sao Jose Do Rio Preto, Sao Paulo, Brazil
Local Institution - 0196
🇮🇱Tel Aviv, Tel-Aviv, Israel
Local Institution - 0176
🇯🇵Hidaka-shi, Saitama, Japan
Local Institution - 0035
🇮🇹Roma, Italy
Local Institution - 0175
🇯🇵Takatsuki City, Osaka, Japan
Local Institution - 0198
🇫🇷Angers, France
Local Institution - 0080
🇩🇪Goettingen, Germany
Local Institution - 0220
🇰🇷Busan, Korea, Republic of
Local Institution - 0206
🇫🇷La Tronche, France
Local Institution - 0015
🇩🇪Erfurt, Germany
Local Institution - 0199
🇫🇷Clermont-ferrand, France
Local Institution - 0200
🇫🇷Montpellier Cedex 5, France
Local Institution - 0095
🇧🇷Jau, Sao Paulo, Brazil
Local Institution - 0067
🇮🇱Ramat Gan, Israel
Local Institution - 0098
🇧🇷Barretos, Sao Paulo, Brazil
Local Institution - 0081
🇩🇪Essen, Germany
Local Institution - 0079
🇩🇪Magdeburg, Germany
Local Institution - 0193
🇮🇹Forlì, Italy
Local Institution - 0168
🇯🇵Niigata-shi, Niigata, Japan
Local Institution - 0184
🇯🇵Sapporo, Hokkaido, Japan
Local Institution - 0218
🇰🇷Daegu, Korea, Republic of
Local Institution - 0075
🇫🇷Marseille, France
Local Institution - 0188
🇫🇷Saint Herblain Cedex, France
Local Institution - 0003
🇫🇷TOULOUSE Cedex 9, France
Local Institution - 0032
🇮🇹Milano, Italy
Local Institution - 0203
🇰🇷Seongnam-si, Kyǒnggi-do, Korea, Republic of
Local Institution - 0178
🇯🇵Minato-ku, Tokyo, Japan
Local Institution - 0169
🇯🇵Yokohama, Kanagawa, Japan
Local Institution - 0163
🇫🇷Paris, France
Local Institution - 0100
🇩🇪Mainz, Rheinland-Pfalz, Germany
Local Institution - 0202
🇫🇷Brest, Cedex, France
Local Institution - 0064
🇮🇹Bari, Italy
Local Institution - 0174
🇯🇵Fukuoka, Japan
Local Institution - 0066
🇮🇱Haifa, Israel
Local Institution - 0179
🇯🇵Tsukuba-shi, Ibaraki, Japan
Local Institution - 0173
🇯🇵Osakasayama, Osaka, Japan
Local Institution - 0033
🇮🇹Padova, Italy
Local Institution - 0171
🇯🇵Kita-gun, Kagawa, Japan
Local Institution - 0177
🇯🇵Sapporo, Hokkaido, Japan
Local Institution - 0208
🇰🇷Gyeongsangnam-do, Korea, Republic of
Local Institution - 0136
🇰🇷Seoul, Korea, Republic of
Local Institution - 0127
🇬🇧York, Yorkshire, United Kingdom
Local Institution - 0124
🇬🇧Oxford, United Kingdom
Local Institution - 0121
🇬🇧London, United Kingdom
Local Institution - 0111
🇪🇸Madrid, Spain
Local Institution - 0112
🇪🇸Madrid, Spain
Local Institution - 0109
🇪🇸Sevilla, Spain
Local Institution - 0113
🇪🇸Lugo, Spain
Local Institution - 0156
🇪🇸Malaga, Spain
Local Institution - 0005
🇺🇸Chicago, Illinois, United States
Local Institution - 0191
🇺🇸Cleveland, Ohio, United States
Local Institution - 0128
🇬🇧Chelmsford, Essex, United Kingdom
Local Institution - 0092
🇧🇷Ijui, RIO Grande DO SUL, Brazil
Local Institution - 0038
🇦🇺Murdoch, Western Australia, Australia
Local Institution - 0097
🇧🇷Porto Alegre, RIO Grande DO SUL, Brazil
Local Institution - 0011
🇦🇹Linz, Austria
Local Institution - 0054
🇨🇱Santiago, Metropolitana, Chile
Local Institution - 0051
🇦🇷Capital Federal, Buenos Aires, Argentina
Local Institution - 0012
🇦🇹Wien, Austria
Local Institution - 0049
🇦🇷Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0052
🇨🇱Santiago, Metropolitana, Chile
Local Institution - 0210
🇨🇱Santiago, Metropolitana, Chile
Local Institution - 0103
🇨🇴Monteria, Colombia
Local Institution - 0204
🇫🇷Créteil, Val-de-Marne, France
Local Institution - 0195
🇬🇷Athens, Attikí, Greece
Local Institution - 0091
🇦🇹Krems, Austria
Local Institution - 0104
🇨🇴Bucaramanga, Colombia
Local Institution - 0159
🇨🇦Kelowna, British Columbia, Canada
Local Institution - 0102
🇲🇽Zapopan, Jalisco, Mexico
Local Institution - 0201
🇨🇴Colombia, Bogota, Colombia
Local Institution - 0145
🇫🇮Tampere, Finland
Local Institution - 0058
🇷🇴Sector 2, Romania
Local Institution - 0141
🇨🇳Taipei City, Taiwan
Local Institution - 0031
🇬🇷Larissa, Thessalía, Greece
Local Institution - 0133
🇳🇴Oslo, Norway
Local Institution - 0219
🇷🇴Cluj-Napoca, Romania
Local Institution - 0135
🇨🇳Kaohsiung, Taiwan
Local Institution - 0139
🇨🇳Taipei, Taiwan
Local Institution - 0160
🇲🇽La Paz, BAJA Californa SUR, Mexico
Local Institution - 0056
🇲🇽Monterrey, Nuevo LEON, Mexico
Local Institution - 0076
🇷🇴Craiova, Romania
Local Institution - 0165
🇨🇳Taichung, Taiwan
Local Institution - 0153
🇵🇹Lisboa, Portugal
Local Institution - 0154
🇸🇬Singapore, Singapore
Local Institution - 0192
🇨🇦Chicoutimi, Quebec, Canada
Local Institution - 0190
🇨🇦Montreal, Quebec, Canada
Local Institution - 0122
🇬🇧Glasgow, United Kingdom
Local Institution - 0117
🇬🇧Lancaster, United Kingdom
Local Institution - 0217
🇫🇷Bordeaux, France
Local Institution - 0002
🇫🇷Strasbourg Cedex, France
Local Institution - 0074
🇫🇷Nice, France
Local Institution - 0047
🇺🇸New York, New York, United States
Local Institution - 0144
🇺🇸Atlanta, Georgia, United States
Local Institution - 0021
🇺🇸Littleton, Colorado, United States
Local Institution - 0022
🇺🇸Tucson, Arizona, United States
Local Institution - 0036
🇺🇸Pensacola, Florida, United States
Local Institution - 0181
🇺🇸Columbia, Maryland, United States
Local Institution - 0029
🇺🇸Albany, New York, United States
Local Institution - 0028
🇺🇸Tigard, Oregon, United States
Local Institution - 0030
🇺🇸Austin, Texas, United States
Local Institution - 0023
🇺🇸Norfolk, Virginia, United States
Local Institution - 0090
🇦🇹Klagenfurt Am Woerthersee, Austria
Local Institution - 0094
🇧🇷Fortaleza, Ceara, Brazil
Local Institution - 0212
🇧🇷Porto Alegre, RIO Grande DO SUL, Brazil
Local Institution - 0053
🇨🇱Santiago, Metropolitana, Chile
Local Institution - 0148
🇫🇮Helsinki, Finland
Local Institution - 0101
🇫🇷Besancon, France
Local Institution - 0020
🇫🇷Pierre Benite Cedax, France
Local Institution - 0086
🇩🇪Frankfurt Main, Germany
Local Institution - 0085
🇩🇪Trier, Germany
Local Institution - 0010
🇩🇪Jena, Germany
Local Institution - 0082
🇩🇪Muenchen, Germany
Local Institution - 0065
🇮🇹Modena, Italy
Local Institution - 0194
🇬🇷Chaidari, Greece
Local Institution - 0068
🇮🇱Beer Sheva, Israel
Local Institution - 0034
🇮🇹Pisa, Italy
Local Institution - 0186
🇯🇵Komaki, Aichi, Japan
Local Institution - 0170
🇯🇵Hamamatasu, Shizuoka, Japan
Local Institution - 0172
🇯🇵Shinjuku-ku, Tokyo, Japan
Local Institution - 0180
🇯🇵Kyoto, Japan
Local Institution - 0137
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
Local Institution - 0215
🇰🇷Seongnam-si,, Korea, Republic of
Local Institution - 0140
🇰🇷Seoul, Korea, Republic of
Local Institution - 0211
🇰🇷Seoul, Korea, Republic of
Local Institution - 0138
🇰🇷Seoul, Korea, Republic of
Local Institution - 0070
🇳🇱Amsterdam, Netherlands
Local Institution - 0105
🇲🇽Colima, Mexico
Local Institution - 0073
🇳🇱Sittard-Geleen, Netherlands
Local Institution - 0072
🇳🇱Groningen, Netherlands
Local Institution - 0087
🇳🇿Auckland, New Zealand
Local Institution - 0089
🇳🇿Christchurch, New Zealand
Local Institution - 0158
🇳🇴Gralum, Norway
Local Institution - 0132
🇳🇴Lorenskog, Norway
Local Institution - 0152
🇵🇹Porto, Portugal
Local Institution
🇷🇺St Petersburg, Russian Federation
Local Institution - 0114
🇪🇸Madrid, Spain
Local Institution - 0185
🇯🇵Sapporo, Hokkaido, Japan
UC Davis Comprehensive Cancer Center
🇺🇸Sacramento, California, United States
Local Institution - 0004
🇺🇸Tampa, Florida, United States
Local Institution - 0009
🇺🇸Boston, Massachusetts, United States
Local Institution - 0166
🇺🇸Boston, Massachusetts, United States
Local Institution - 0209
🇺🇸Boston, Massachusetts, United States
Local Institution - 0025
🇺🇸Minneapolis, Minnesota, United States
Local Institution - 0129
🇺🇸Minneapolis, Minnesota, United States
Local Institution - 0183
🇺🇸Omaha, Nebraska, United States
Local Institution - 0001
🇺🇸Omaha, Nebraska, United States
Local Institution - 0024
🇺🇸Las Vegas, Nevada, United States
Local Institution - 0189
🇺🇸Charleston, South Carolina, United States
Local Institution - 0007
🇺🇸Nashville, Tennessee, United States